Job Description
pAbRegulatoryAffairsSeniorSpecialist/bwillreporttotheManagerRegulatoryAffairsandbeinvolvedinallaspectsofregulatoryaffairsincludingexistinglicensedproductsandproductsunderdevelopment./ppbResponsibilities:/bulliPrepareandmaintainhighqualitydossiersformarketingauthorisationapplicationsandresponsestohealthauthorityquestions./liliSubmitCPPandmanufacturingauthorisationrequeststoHPRAandMHRA./liliReviewdataforsubmissionandadviseondeficienciesorissues./liliEnsureon-timesubmissionsforqualityandsafetyrelatedchanges./liliPrepareandsubmittranslatedtextstoEUandNon-EUcountries./liliUpdatedatabasesandsystemsforallproducts./liliLiaisewith3rdpartiestoestablisheffectivecommunicationandrelationships./liliLiaisewithBusinessDevelopment,ProductLaunch,Artwork,SupplyChainandQualitycolleagues./liliAdvisemanagementonprojectstatusandprogress./liliMaintainawarenessofregulatoryrequirementsandensureHealthAuthoritycompliance./li/ul/ppbRequirements:/bulliMastersorBachelor'sdegreeinScience,TechnologyorPharmacy./liliMinimum5yearsofexperienceinRegulatoryAffairs./liliUnderstandingofhealthauthorityexpectationsforpharmaceuticalsinEU,USandROWregions./liliStrongorganisation,timemanagementandattentiontodetailskills./liliExcellentcriticalthinkingandproblem-solvingabilities./liliStronginterpersonalandcommunicationskills./liliExperienceindealingwithmultiplestakeholders./li/ul/ppbBenefits:/bWorkFromHome